Research Ethics & Compliance
Dr Simon Barrett
Manager, Research Ethics & Compliance
Monash Research Office
Legislation:
 Prevention of Cruelty to Animals Act 1986
 NHMRC Act 1992
 ARC Act 2001
 Prohibition of Human Cloning Act 2002
 Research Involving Human Embryo Act 2002
 Gene Technology Act 2000
 Quarantine Act 1908
 National Health Security Act 2007
 Privacy Act 2000
Codes of Practice
 NHMRC & ARC
– Australian Code for the Responsible Conduct of Research
– Australian Code of Practice for the Care and Use of Animals
for Scientific Purpose
– The National Statement on Ethical Conduct in Human
Research
– Guidelines for Ethical Conduct in Aboriginal and Torres
Strait Islander Health Research
………………………………………….And many more
Review Processes
 Monash University Human Research Ethics Committee
 Animal Ethics Committees (10 x local)
 Monash University Institutional Biosafety Committee
What is Human Research?
 Taking part in surveys, interviews or focus groups
 Undergoing psychological, physiological or medical testing or
treatment
 Being observed by researchers
 Researchers having access to personal documents or other
materials
 Collecting organs, tissues, fluids or exhaled breath
 Access to information (individually identifiable, re-identifiable or
non-identifiable) as part of an existing published or unpublished
source or database
Risk and Benefit
 benefits justify the risks
 level of ethical review should reflect the level of risk
Consent
 Participation is voluntary
 Consent must be informed
– Sufficient information to understand the purpose,
demands, risks and potential benefits.
Applications:
 “Low Risk” Research (Form LR)
~ 2 weeks
 Greater than “Low Risk” Research (Form 1)
~ 8 weeks
 Multi Centre
~ 1 week
Animal Ethics Review:
 All Monash scientific activities (teaching or research) using animals
requires approval from a Monash AEC before work can commence.
Animal Welfare General Principles:
 Justification
 Responsibilities
 Replacement
 Reduction
 Refinement
Applications:
 Applications are made to local AEC
 Must be reviewed by full committee in “face to face” meeting.
 Application usually require amendments
 Often approved once amendments are received by secretary
and reviewed by chair.
 Average approval ~ 60 days
Gene Technology (GT) Act, 2000
 Introduces a national scheme for the regulation
of GMOs in Australia
 Protect the health and safety of Australians and
the environment
 Identify and manage the risks posed by or as a
result of gene technology
Requirements of the GT Act
 Organisations undertaking dealings are “Accredited”
 Dealings are classified based on their level of risk
– Exempt
– Notifiable Low Risk Dealings
– Licensed (non-intentional release & intentional release)
 Facilities for certain “Dealings” are “Certified”
Applications:
 Application received at anytime.
 Approvals
– Exempt - immediate
– Notifiable Low Risk Dealings ~ 2 weeks
– Dealings Not Involving Release or Dealings Involving Release
must await approval from OGTR ~ up to 90 business days
Quarantine Act 1908 (Regulations 2000)
 Controls Australia’s borders to minimise the risk of exotic pests and
diseases to agriculture industries and the environment
 Import and Export Inspection and Certification
 Australia is currently free from a number of biological threats, such as
foot and mouth disease, that have had major economic and
environmental consequences for other countries
Import Permits
Import permits are required for the following examples of goods:
– Human/animal tissue, blood, fluid, sera samples
– Cell lines
– Laboratory Reagents
• Eg. Proteins, peptides, lipids, hormones, enzymes, etc.
– Genetic Material
– Micro-organisms
– Antibodies/antiserum
– Diagnostic Kits
• Eg. ELISA kits
– Soil/water samples
– Plants
– Animals (including insects)
Import Permits
 Allows researchers to import goods which are subject to quarantine
 Contains post entry conditions requiring that the goods be restricted to
specified quarantine facilities, also known as Quarantine Approved
Premises (QAPs)
 Specifies the level of containment required for the goods
 ALL import permits for the University are now applied for through the
Research Compliance Office
Funding Bodies
 Requirement of clearances
– Funds aren’t released until clearance approvals have been sited.
 Code for the Responsible Conduct of Research
– “Compliance with the code is a prerequisite for the receipt of
NHMRC and ARC funding”
What you need to know.
That……
 Approvals for you work are in place
 You names are added to any existing or new approvals
 Be familiar with the content of the approved application
 Be familiar with any conditions of approval…..and comply with them